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Johnson & Johnson begins Phase 1 trial of preventive Ebola vaccine program

Johnson & Johnson today announced the start of a Phase 1, first-in-human clinical trial of a preventive Ebola vaccine in development at its Janssen Pharmaceutical Companies.

6 Jan 2015

Clementia secures additional $10 million to support development of palovarotene for treatment of FOP

Clementia Pharmaceuticals, Inc. today announced that it has secured an additional $10 million from current investors to support development of the company's lead compound palovarotene for the treatment of fibrodysplasia ossificans progressive (FOP).

5 Jan 2015

Sirnaomics submits STP705 IND Application to CFDA for skin scar treatment

Sirnaomics, Inc. and its affiliate Suzhou Sirnaomics Pharmaceutics, Co. Ltd., together with its partner Guangzhou Xiangxue Pharmaceutical, Co. Ltd., (SZSE: 300147), have formally submitted an Investigational New Drug (IND) Application to the China Food and Drug Administration for STP705, an anti-fibrosis RNA interference (RNAi) therapeutic for prevention and treatment of human skin hypertrophic scars.

5 Jan 2015

OncoGenex executes initial agreement with Teva to regain rights to custirsen

OncoGenex Pharmaceuticals, Inc. today announced that it has executed an initial agreement with Teva Pharmaceutical Industries Ltd. to regain rights to custirsen, an investigational compound currently being evaluated in Phase 3 clinical development as a treatment for prostate and lung cancers.

31 Dec 2014

LIBD announces significant advances in identifying causes of schizophrenia, brain disorders

The Lieber Institute for Brain Development (LIBD) announces significant advances in identifying the causes of schizophrenia and related developmental brain disorders and translating these findings into new treatment strategies.

31 Dec 2014

Anthera Pharmaceuticals to host Lupus symposium in San Francisco

Anthera Pharmaceuticals, Inc. today announced that it is inviting its shareholders and investors to a symposium on Systemic Lupus Erythematosus (SLE) at 3:30 PM on Wednesday, January 14th at the Mystic Hotel in San Francisco, CA.

31 Dec 2014

G-treeBNT files IND with MFDS for Phase IIB/III clinical trial of RGN-259 for dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. announced that its strategic partner, G-treeBNT Co. Ltd., has filed an IND with the Korean Ministry of Food and Drug Safety for a Phase IIB/III clinical trial with RGN-259 (designated GBT-201 in Korea and the licensed Pan Asia territory) for the treatment of patients with dry eye syndrome.

29 Dec 2014

Janssen, Gilead to jointly develop darunavir-based, single-tablet regimen for HIV treatment

Janssen R&D Ireland announced today an amendment to its existing agreement with Gilead Sciences, Inc., initially established in 2011, for the development of a once daily, darunavir-based, single-tablet regimen (STR) for the treatment of people living with HIV.

29 Dec 2014

Palatin begins bremelanotide phase 3 study for treatment of female sexual dysfunction

Palatin Technologies, Inc., a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, today announced that it has started its bremelanotide pivotal registration program.

29 Dec 2014

Newron, Zambon announce re-submission of safinamide NDA to FDA

Newron Pharmaceuticals S.p.A., a research and development company focused on novel CNS and pain therapies, and its commercial and development partner Zambon S.p.A., an international pharmaceutical company, announced today that the NDA for safinamide has been re-submitted to the US FDA.

29 Dec 2014

Protein Sciences earns Frost & Sullivan 2013 Global New Product Innovation Award

Based on its recent analysis of the influenza vaccines market, Frost & Sullivan recognises Protein Sciences with the 2013 Global New Product Innovation Award. Flublok is the world's first recombinant protein vaccine for the prevention of seasonal influenza disease to gain U.S. FDA approval.

29 Dec 2014

Tianyin Pharmaceutical releases unaudited preliminary financial results for Q1 FY 2015

Tianyin Pharmaceutical Inc., a pharmaceutical company that specializes in the patented biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded generics and active pharmaceutical ingredients (API) released unaudited preliminary financial results for the first quarter of fiscal year 2015.

25 Dec 2014

Soligenix closes previously announced registered public offering

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that on December 24, 2014 it closed its previously announced registered public offering.

25 Dec 2014

PlasmaTech Biopharmaceuticals closes underwritten public offering of common stock

PlasmaTech Biopharmaceuticals, Inc., a biopharmaceutical company advancing patient care in critical areas, announced the closing of an underwritten public offering of 3,500,000 shares of common stock, and warrants to purchase up to an aggregate 3,500,000 shares of common stock, at an offering price of $4.00 per share and $.01 per warrant.

25 Dec 2014

Kinex Pharmaceuticals doses first patient with KX2-361 in ‘A Phase 1’ clinical trial

Kinex Pharmaceuticals announced today that the first patient has been dosed with KX2-361 at Roswell Park Cancer Institute.

25 Dec 2014

FDA approves Namzaric drug for treatment of moderate to severe Alzheimer's disease

Actavis plc and Adamas Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric, a fixed-dose combination (FDC) of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor.

25 Dec 2014

EMA validates Synageva's sebelipase alfa MAA for LAL Deficiency

Synageva BioPharma Corp., a biopharmaceutical company developing therapeutic products for rare disorders, today announced validation by the European Medicines Agency of the Marketing Authorization Application for sebelipase alfa for LAL Deficiency.

23 Dec 2014

CorMedix signs Neutrolin sales/distribution agreement with Arabian Trade House

CorMedix Inc., a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious disease, announced today the first signed Middle East sales/distribution agreement for lead product Neutrolin with distributor Arabian Trade House in the Kingdom of Saudi Arabia.

23 Dec 2014

Shandong Taibang Biological Products earns GMP certification for new production facility

China Biologic Products, Inc., a leading fully integrated plasma-based biopharmaceutical company in China, today announced that its majority-owned subsidiary, Shandong Taibang Biological Products Co. Ltd., has received Good Manufacturing Practices ("GMP") certification from the China Food and Drug Administration (the "CFDA") for its new coagulation factor production facility.

23 Dec 2014

IGI Laboratories submits three additional ANDAs to FDA

IGI Laboratories, Inc., a New Jersey based specialty generic pharmaceutical company, today announced it has submitted three additional abbreviated new drug applications (ANDAs) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to eleven, with twenty-two submissions now pending at the FDA.

23 Dec 2014

Pharmaceuticals News and Research

Johnson & Johnson begins Phase 1 trial of preventive Ebola vaccine program

Clementia secures additional $10 million to support development of palovarotene for treatment of FOP

Sirnaomics submits STP705 IND Application to CFDA for skin scar treatment

OncoGenex executes initial agreement with Teva to regain rights to custirsen

LIBD announces significant advances in identifying causes of schizophrenia, brain disorders

Anthera Pharmaceuticals to host Lupus symposium in San Francisco

G-treeBNT files IND with MFDS for Phase IIB/III clinical trial of RGN-259 for dry eye syndrome

Janssen, Gilead to jointly develop darunavir-based, single-tablet regimen for HIV treatment

Palatin begins bremelanotide phase 3 study for treatment of female sexual dysfunction

Newron, Zambon announce re-submission of safinamide NDA to FDA

Protein Sciences earns Frost & Sullivan 2013 Global New Product Innovation Award

Tianyin Pharmaceutical releases unaudited preliminary financial results for Q1 FY 2015

Soligenix closes previously announced registered public offering

PlasmaTech Biopharmaceuticals closes underwritten public offering of common stock

Kinex Pharmaceuticals doses first patient with KX2-361 in ‘A Phase 1’ clinical trial

FDA approves Namzaric drug for treatment of moderate to severe Alzheimer's disease

EMA validates Synageva's sebelipase alfa MAA for LAL Deficiency

CorMedix signs Neutrolin sales/distribution agreement with Arabian Trade House

Shandong Taibang Biological Products earns GMP certification for new production facility

IGI Laboratories submits three additional ANDAs to FDA

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